1.Clinical research and characteristic analysis of patients with advanced colorectal cancer treated with Yinyang Gongji Pills and capecitabine.
Lei WANG ; Chao-Yue YAO ; Jie-Ru ZHAN ; Xiao-Xia SUN ; Zhong-Xin YU ; Xiao-Ya LIANG ; Jian WANG ; Xue GONG ; Da-Rong WEI
China Journal of Chinese Materia Medica 2025;50(5):1404-1411
Yinyang Gongji Pills have the effects of strengthening the body resistance to eliminate pathogenic factors, removing stasis, and reducing swelling, which is a commonly used traditional Chinese medicine(TCM) formula for treating intestinal accumulation. A real-world, registered, and single-arm clinical trial was conducted to observe the clinical efficacy and safety of Yinyang Gongji Pills combined with capecitabine in the treatment of advanced colorectal cancer and analyze the clinical characteristics of the patients. A total of 60 patients with advanced colorectal cancer who refused or could not tolerate standard treatment of western medicine were included in the study. They were treated with Yinyang Gongji Pills combined with capecitabine until disease progression or intolerable adverse events occurred. The main observation indicators were progression-free survival(PFS) and safety. The treatment effects of the patients under different baseline characteristics were analyzed. The clinical trial has found that the median PFS of all enrolled patients was 7.3 months, with 30.1% of patients having a PFS exceeding 12.0 months. Layered analysis showed that the median PFS of patients with the onset site being the colon and rectum were respectively 8.4 and 4.7 months. The median PFS of patients with high, medium, and low tumor burden were respectively 7.0, 4.7, and 10.8 months. The median PFS of patients with wild-type and mutant-type RAS/BRAF were respectively 7.9 and 6.9 months. The median PFS of patients with KPS scores ≥80 and ≤70 were respectively 7.9 and 6.5 months. The median PFS of patients treated with Yinyang Gongji Pills for ≥6, 3-6, and ≤3 months were respectively 8.0, 5.2, and 4.2 months. The median PFS of patients with spleen, kidney, liver, and lung syndrome differentiation in TCM were respectively 8.3, 6.7, 7.3, and 5.6 months. The median PFS of patients with TCM pathological factors including phlegm, dampness, and blood stasis were respectively 7.0, 7.3, and 6.5 months. Common adverse reactions include anemia, decreased white blood cells, decreased appetite, fatigue, and hand foot syndrome, with incidence rates being respectively 44.2%, 34.6%, 42.3%, 32.7%, and 17.3%. The results showed that the combination of Yinyang Gongji Pills and capecitabine demonstrated potential clinical efficacy and good safety in this study. The patients have clinical characteristics such as low tumor burden, onset site at the colon, KPS scores ≥ 80, long duration of oral TCM, and TCM syndrome differentiation including spleen or liver.
Humans
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Capecitabine/adverse effects*
;
Colorectal Neoplasms/mortality*
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Drugs, Chinese Herbal/adverse effects*
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Male
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Middle Aged
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Female
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Aged
;
Adult
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Treatment Outcome
2.Research progress on the cGAS-STING signaling pathway in immune-mediated inflammatory diseases in children.
Xin-Yue WEI ; Xiao-Juan GONG ; Hong JI
Chinese Journal of Contemporary Pediatrics 2025;27(7):881-887
The cyclic GMP-AMP synthase (cGAS)-stimulator of interferon gene (STING) signaling pathway is a crucial component of the immune system. It detects abnormal cytosolic double-stranded DNA and promotes the expression of type I interferons and other inflammatory factors, thereby protecting the body from pathogenic infections. In children, an immature immune system or genetic mutations can lead to immune dysregulation, increasing the risk of autoimmune diseases (AID) and autoinflammatory diseases. Recent studies have shown that aberrant activation of the cGAS-STING signaling pathway is associated with the development of AID and autoinflammatory diseases in children. This review summarizes the research progress on the cGAS-STING signaling pathway in childhood AID and autoinflammatory diseases, aiming to provide new directions for clinical diagnosis and treatment.
Humans
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Nucleotidyltransferases/physiology*
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Membrane Proteins/physiology*
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Signal Transduction/physiology*
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Child
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Autoimmune Diseases/immunology*
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Inflammation/etiology*
3.Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
Ying-Qiang ZHAO ; Yong-Fa XING ; Ke-Yong ZOU ; Wei-Dong JIANG ; Ting-Hai DU ; Bo CHEN ; Bao-Ping YANG ; Bai-Ming QU ; Li-Yue WANG ; Gui-Hong GONG ; Yan-Ling SUN ; Li-Qi WANG ; Gao-Feng ZHOU ; Yu-Gang DONG ; Min CHEN ; Xue-Juan ZHANG ; Tian-Lun YANG ; Min-Zhou ZHANG ; Ming-Jun ZHAO ; Yue DENG ; Chang-Jiang XIAO ; Lin WANG ; Bao-He WANG
Chinese journal of integrative medicine 2025;31(8):685-693
OBJECTIVE:
To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents.
METHODS:
This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs).
RESULTS:
This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed.
CONCLUSION
STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans
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Double-Blind Method
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Drugs, Chinese Herbal/adverse effects*
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Male
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Female
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Middle Aged
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Angina, Stable/physiopathology*
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Aged
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Syndrome
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Treatment Outcome
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Placebos
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Tablets
4.Glucocorticoid Discontinuation in Patients with Rheumatoid Arthritis under Background of Chinese Medicine: Challenges and Potentials Coexist.
Chuan-Hui YAO ; Chi ZHANG ; Meng-Ge SONG ; Cong-Min XIA ; Tian CHANG ; Xie-Li MA ; Wei-Xiang LIU ; Zi-Xia LIU ; Jia-Meng LIU ; Xiao-Po TANG ; Ying LIU ; Jian LIU ; Jiang-Yun PENG ; Dong-Yi HE ; Qing-Chun HUANG ; Ming-Li GAO ; Jian-Ping YU ; Wei LIU ; Jian-Yong ZHANG ; Yue-Lan ZHU ; Xiu-Juan HOU ; Hai-Dong WANG ; Yong-Fei FANG ; Yue WANG ; Yin SU ; Xin-Ping TIAN ; Ai-Ping LYU ; Xun GONG ; Quan JIANG
Chinese journal of integrative medicine 2025;31(7):581-589
OBJECTIVE:
To evaluate the dynamic changes of glucocorticoid (GC) dose and the feasibility of GC discontinuation in rheumatoid arthritis (RA) patients under the background of Chinese medicine (CM).
METHODS:
This multicenter retrospective cohort study included 1,196 RA patients enrolled in the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) from September 1, 2019 to December 4, 2023, who initiated GC therapy. Participants were divided into the Western medicine (WM) and integrative medicine (IM, combination of CM and WM) groups based on medication regimen. Follow-up was performed at least every 3 months to assess dynamic changes in GC dose. Changes in GC dose were analyzed by generalized estimator equation, the probability of GC discontinuation was assessed using Kaplan-Meier curve, and predictors of GC discontinuation were analyzed by Cox regression. Patients with <12 months of follow-up were excluded for the sensitivity analysis.
RESULTS:
Among 1,196 patients (85.4% female; median age 56.4 years), 880 (73.6%) received IM. Over a median 12-month follow-up, 34.3% (410 cases) discontinued GC, with significantly higher rates in the IM group (40.8% vs. 16.1% in WM; P<0.05). GC dose declined progressively, with IM patients demonstrating faster reductions (median 3.75 mg vs. 5.00 mg in WM at 12 months; P<0.05). Multivariate Cox analysis identified age <60 years [P<0.001, hazard ratios (HR)=2.142, 95% confidence interval (CI): 1.523-3.012], IM therapy (P=0.001, HR=2.175, 95% CI: 1.369-3.456), baseline GC dose ⩽7.5 mg (P=0.003, HR=1.637, 95% CI: 1.177-2.275), and absence of non-steroidal anti-inflammatory drugs use (P=0.001, HR=2.546, 95% CI: 1.432-4.527) as significant predictors of GC discontinuation. Sensitivity analysis (545 cases) confirmed these findings.
CONCLUSIONS
RA patients receiving CM face difficulties in following guideline-recommended GC discontinuation protocols. IM can promote GC discontinuation and is a promising strategy to reduce GC dependency in RA management. (Trial registration: ClinicalTrials.gov, No. NCT05219214).
Adult
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Aged
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Female
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Humans
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Male
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Middle Aged
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Arthritis, Rheumatoid/drug therapy*
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Glucocorticoids/therapeutic use*
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Medicine, Chinese Traditional
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Retrospective Studies
6.Study of an Assessment Tool for Social Care Needs of Terminal Patients at Home and its reliability and validity
Yao XIAO ; Xiaotian ZHANG ; Yongting WEI ; Yinghui MA ; Ni GONG ; Jing YANG ; Zishen WANG ; Peng YUE
Chinese Journal of Nursing 2025;60(1):99-105
Objective A Social Care Needs Assessment Tool for Terminal Patients at Home is constructed and tested for its reliability and validity.Methods In view of the Social Ecosystem Theoiy,based on the semi-structured interviews,participatory observation and literature analysis of the social care needs of terminal patients at home,a questionnaire item pool was formed.Through 3 rounds of Delphi expert consultations,the initial version of the tool was formed.From April to December 2023,a convenient sampling method was used to select 504 terminal patients from 22 hospitals in 5 provinces as the research subjects.The reliability and validity of the tool were tested.Result The constructed tool in this study contained 3 dimensions:micro,meso,macro,with a total of 34 items.Cronbach's α of the tool was 0.966 and split-half reliability was 0.877;I-CVI at the item level was 0.875~1.000 and S-CVI/Ave was 0.989;the exploratory factor analysis results showed that the factors load of each dimension were greater than 0.4;the results of confirmatory factor analysis showed that the tool had good fitting degree.Conclusion The reliability and validity of the nursing-based social care needs assessment tool for terminal patients at home constructed in this study are good,and it can provide a valid tool for healthcare professionals to assess the home-based social care needs of terminal patients.
7.Construction and performance evaluation of a prediction model for postoperative poor in-hospital prognosis in patients with traumatic brain injury
Tao MEI ; Zheyong JIA ; Lie CHEN ; Peng CAO ; Wei XIAO ; Weiqiang MAO ; Jianwu GONG ; Lixin XU
Chinese Journal of Trauma 2025;41(11):1048-1058
Objective:To construct a prediction model for postoperative poor in-hospital prognosis in patients with traumatic brain injury (TBI) and evaluate its predictive performance.Methods:A retrospective case control study was conducted to analyze the clinical data of 1 120 TBI patients admitted to Changde Hospital Affiliated to Xiangya Medical College of Central South University from May 2019 to December 2024. The patients were divided into the training set ( n=784) and verification set ( n=336) at a ratio of 7∶3. Based on the Glasgow outcome scale-extended (GOS-E) at discharge, the training set was stratified into favorable prognosis group ( n=335, GOS-E 5-8 points) and poor prognosis group ( n=449, GOS-E 1-4 points). The two groups in the training set were compared in terms of general baseline indicators, TBI-related clinical indicators, and admission laboratory blood test results. Univariate analysis and Lasso regression analysis were employed to screen risk factors associated with postoperative poor in-hospital prognosis in TBI patients. Multivariate Logistic regression analysis was used to determine independent risk factors and construct a regression equation. The regression equation was presented using R language to create a visual nomogram for predicting postoperative poor in-hospital prognosis in TBI patients. In both the training set and verification set, the predictive performance of the model was evaluated by calculating the area under the receiver operating characteristic (ROC) curve (AUC), plotting calibration curves, and performing decision curve analysis (DCA). Results:The results of the univariate analysis indicated that the age, Charlson complication index (CCI), time from trauma to admission, time from trauma to operation, cause of injury, abbreviated injury scale (AIS) (head and neck), injury severity score (ISS), admission Glasgow coma scale (GCS), admission pupil responsiveness, multiple craniocerebral injuries, subdural hematoma, intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, decompressive craniotomy, intraoperative blood loss, intraoperative blood transfusion, traumatic cerebral infarction, postoperative delayed bleeding, epilepsy seizures, as well as the following admission tested results including red blood cell count, white blood cell count, platelet count, neutrophil percentage, percentage of lymphocytes, albumin, total bilirubin, urea nitrogen, thrombin time (TT), prothrombin time (PT), international standardized ratio (INR), glutamic aminotransferase, alanine aminotransferase, creatinine, and blood glucose were statistically different between the two groups in the training set ( P<0.05). Lasso regression analysis suggested 14 risk factors of age, CCI, cause of injury, head and neck AIS, ISS, admission GCS, admission pupil responsiveness, multiple craniocerebral injuries, subdural hematoma, intracerebral hematoma, intraoperative blood loss, admission platelet count, admission albumin, admission blood glucose for postoperative poor in-hospital prognosis. The results of the multivariate Logistic regression analysis showed that age ( OR=1.02, 95% CI 1.00, 1.03, P<0.01), CCI ( OR=1.46, 95% CI 1.02, 2.09, P<0.05), head and neck AIS ( OR=1.43, 95% CI 1.11, 1.85, P<0.01), ISS ( OR=2.16, 95% CI 1.39, 3.35, P<0.01), admission GCS ( OR=1.59, 95% CI 1.19, 2.13, P<0.01), intracerebral hematoma ( OR=4.41, 95% CI 2.15, 9.44, P<0.01), intraoperative blood loss ( OR=1.05, 95% CI 1.00, 1.09, P<0.05), admission platelet count ( OR=0.98, 95% CI 0.97, 0.99, P<0.01), admission blood glucose ( OR=1.08, 95% CI 1.02, 1.15, P<0.05) could be the main risk factors to construct a prediction model for postoperative poor in-hospital prognosis in TBI patients. Meanwhile, a regression equation was constructed: Logit[ P/(1- P)]=-2.4+ 0.02×"age"+0.38×"CCI"+0.36×"head and neck AIS"+0.77×"ISS"+0.47×"admission GCS"+1.48×"intracerebral hematoma"+0.05×intraoperative blood loss-0.02×admission platelet count+0.08×admission blood glucose. In the training set, the predictive model for poor postoperative in-hospital prognosis in TBI patients achieved an AUC of 0.87 (95% CI 0.84, 0.89), with a Youden′s index of 0.57, sensitivity of 73.70%, and specificity of 83.00%. In the verification set, the model showed an AUC of 0.80 (95% CI 0.76, 0.85), with a Youden′s index of 0.63, sensitivity of 65.20%, and specificity of 77.90%. In the training set, the Brier score for the calibration curve was 0.14 (95% CI 0.13, 0.16). In the verification set, the Brier score for the calibration curve was 0.18 (95% CI 0.15, 0.20). The DCA diagram indicated that the nomogram prediction model provided high clinical net benefit for predicting postoperative poor in-hospital prognosis in TBI patients. Conclusion:The prediction model for postoperative poor in-hospital prognosis in TBI patients, constructed based on age, CCI, head and neck AIS, ISS, admission GCS, intracerebral hematoma, intraoperative blood loss, admission platelet count, and admission blood glucose, exhibits good predictive performance.
8.The effects of exercise based on the sports and medical care integration model on the community-dwelling persons with type 2 diabetes mellitus
Mengjing XIAO ; Li XU ; Cunshu WU ; Lijun WEI ; Baoyi CHEN ; Xiang GONG ; Jun LU ; Guangxu XU
Chinese Journal of Physical Medicine and Rehabilitation 2025;47(4):343-348
Objective:To explore the effect of exercise on glycemic control and physical indicators among community-dwelling persons with type 2 diabetes mellitus (T2DM).Methods:A total of 42 T2DM patients undergoing regular follow-up at a community health center were divided into a control group and an exercise group. To minimize confounding factors, 1∶1 propensity score matching was performed, resulting in 21 patients in each group. Both groups received standardized diabetes management, including medication, dietary guidance and diabetes health education. The exercise group additionally performed exercises which integrated sports and medical care models. The experiment lasted 8 weeks. Before and after the intervention, glycosylated hemoglobin A1c (HbA1c) levels, body weight, body mass index (BMI), fat mass, visceral fat area (VFA), fat mass index (FMI) and appendicular skeletal muscle mass index (ASMI) were recorded and compared between the two groups. Moreover, the actual exercise compliance of the exercise group was observed, along with any adverse events such as hypoglycemia or exercise-related injuries, as well as changes in antidiabetic medication dosage.Results:After the intervention, significant improvement was observed in both groups in all of the measurements, but with the average HbA1c, BMI, fat mass, VFA and FMI values of the exercise group then significantly better than the control group′s averages. The average compliance rate in the exercise group was 60%. No cases of hypoglycemia or exercise-related injuries were reported during the intervention, and there were no changes in the use of anti-diabetes medications.Conclusions:Exercise effectively improves glycemic control and physical indicators among community-dwelling T2DM patients. However, exercise compliance needs improving.
9.Competitive Immunoassay for Detection of Enrofloxacin Based on Metasurface Plasma Resonance Chip Coupled with Gold Nanoparticles
Wei-Hao JI ; Hong-Li FAN ; Lei GONG ; Li-Ping HUANG ; Xiao-Long FAN ; Jia-Yong HU ; Tao-Hong ZHOU ; Gang LIU
Chinese Journal of Analytical Chemistry 2025;53(5):814-822
Risks of food safety induced by small molecule drug residues in animal food and environment have become an increasing public concern,so it is necessary to develop highly sensitive and easy-to-operate techniques to detect small molecules.Herein,a metasurface plasma resonance(MetaSPR)sensor chip coupled with gold nanoparticles(AuNPs)was developed for detection of enrofloxacin(ENR)based on competitive immunoassay.The detection range of the sensor for ENR was 0.025-3.2 ng/mL,and the detection limit(3σ)was 20 pg/mL.The biosensor showed excellent performance including high selectivity,good stability,ease to operate and high throughput,etc.The developed method was applied to detection of ENR residues in real samples,with recoveies of 96.0% -105.0%.The proposed sensing strategy provided new technique reference for detection of other small molecules in the field of residue analysis in food safety and environment monitoring.
10.Investigation and analysis of the reasons for unconformity of positive and reverse ABO blood typing by microcolumn gel method in 425 cases
Weihuan XIAO ; Caiping GONG ; Ruixing YE ; Wei XIANG
International Journal of Laboratory Medicine 2025;46(20):2469-2473
Objective To investigate the situation of unconformity of positive and reverse ABO blood typ-ing between outpatient and inpatient patients in the hospital,and explore the reasons for unconformity of posi-tive and reverse ABO blood typing detected by microcolumn gel method.Methods A retrospective analysis was conducted on the medical records of totally 425 patients with ABO blood type mismatch who underwent ORTHO VISION Max testing in the hospital from August 2023 to December 2024.Comprehensive analysis was conducted using various methods including the saline tube method,irregular antibody screening,increas-ing plasma volume,4 ℃ enhancement test,absorption elution,and gene sequencing,etc.Results Among 128 192 cases of ABO blood type tests,425 cases showed unconformity of positive and reverse ABO blood typ-ing,accounting for 0.33%.The causes were as follows:antibody weakening in 316 cases(74.35%),bone mar-row transplantation in 40 cases(9.41%),interference from irregular antibodies in 34 cases(8.00%),antigen weakening in 13 cases(3.06%),subgroups in 10 cases(2.35%),cold agglutinins in 6 cases(1.41%),inter-ference from irregular and autoantibodies in 4 cases(0.94%),auto-sensitization of red blood cells in 1 case(0.24%),and other reasons in 1 case(0.24%).Among 316 cases with antibody weakening,239 cases(75.63%)involved type A(anti-B weakening),61 cases(19.30%)involved type B(anti-A weakening),8 ca-ses(2.53%)involved type O(anti-A weakening),6 cases(1.91%)involved type O(anti-B weakening),and 2 cases(0.63%)involved type O(both anti-A and anti-B weakening).In patients with antibody weakening,the disease distribution was mainly cardiovascular disease in 127 cases(40.19%),a history of tumors in 67 ca-ses(21.20%),kidney diseases in 11 cases(3.48%),and orthopedic diseases in 10 cases(3.16%).Conclusion The main reason for the unconformity of positive and reverse ABO blood typing in the hospital is the weakening of the antibodies,especially the predominance of type A(anti-B weakening).Weakened anti-bodies are predominantly in the distribution of cardiovascular disease.For subtype-induced disturbances,a comprehensive analysis combining serology and gene sequencing is recommended.For disease-induced uncon-formity of positive and reverse ABO blood typing,monitoring the patients should be strengthened.

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